To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine. [ Time Frame: 28 days after each Dengue vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination. [ Time Frame: Day 28 after each Dengue vaccination ] [ Designated as safety issue: No ]

To provide information concerning the immunogenicity of childhood vaccines after primary vaccination. [ Time Frame: Day 28 after post-vaccination ] [ Designated as safety issue: No ]

Participants will be enrolled in a 3-step enrollment and randomized to 1 of 4 treatment groups. Groups 1 and 2 will receive 5 vaccinations, and Groups 3 and 4 will received 6 vaccinations (childhood vaccines or placebo co-administered with the first dose of CYD Dengue vaccine in 2 separate arms). All toddlers will receive a pentavalent acellular pertussis combination vaccine or Combo (PENTAXIM®), planned approximately 10 months after enrollment.

Eligibility

Ages Eligible for Study:

12 Months to 15 Months

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria :

Toddler in good health based on medical history and medical examination

Toddler aged 12 to 15 months on the day of inclusion

Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

Provision of informed consent form signed by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)

Participant and parent/delegate able to attend all scheduled visits and comply with all trial procedures

Completion of previous vaccination program according to the national immunization schedule, except for measles

Exclusion Criteria :

Family members from the Investigator or from the staff involved in the trial

Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

History of central nervous system disorder or disease, including seizures

History of varicella, measles, mumps, rubella and hepatitis A; confirmed either clinically, serologically, or microbiologically

Previous vaccination against measles-mumps-rubella, hepatitis A or varicella

Previous vaccination against flavivirus diseases

Known systemic hypersensitivity to any of the components of the vaccines, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances

Planned participation in another clinical trial during the present trial period

Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination

Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response

Planned receipt of any vaccine in the 4 weeks following the first trial vaccination

Human immunodeficiency virus (HIV) seropositivity in the blood sample taken at screening

Clinically significant laboratory abnormalities, as judged by the Investigator, in blood sample taken at screening

Temporary exclusions: vaccination postponed until the condition is resolved:

Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment

Receipt of oral or injected antibiotic therapy within 72 hours prior to the vaccination visit

Any vaccination received in the 4 weeks preceding vaccination

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064141